Stability Studies and Estimating Shelf Life

Instructor: Steven Wachs
Product ID: 706026
Training Level: Intermediate
  • Duration: 90 Min
In this webinar attendees will learn the useful methods and techniques for conducting a stability study and analyzing the resulting data for estimating shelf life. This webinar will provide the answers to help participants immediately apply the presented methods. The interpretation and communication of results will be emphasized and illustrated using several examples.

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: May-2019

Training CD / USB Drive

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Read Frequently Asked Questions

Why Should You Attend:

It is essential for manufacturers of foods, drugs, consumer goods, and other products to determine the shelf life of their products. It will help customers identify when the product can be expected to perform as intended. There are many methods to quantify the “shelf-life” of a product. The Method(s) selected are often based on the testing duration available.

In this webinar you will learn the steps involved in setting-up a stability study and in analyzing the results to evaluate the product’s shelf life. How regression models are used to model the relationship between the response variable(s) and time will be presented. Methods for handling non-normal response data will also be discussed. Finally, how accelerating variables can be used to shrink the study time and the models required will be introduced. Many examples that illustrate the methods will also be presented.

This program will cover the following topics:

  • Planning a Stability Study
  • Determining Performance Specifications
  • Defining & Determining Shelf Life
  • Confidence Levels
  • Life Data Analysis Approach for Determining Shelf Life
  • Life Data Analysis with Accelerated Aging
  • Regression Modeling (Linear and Non-Linear) to Assess Stability/Shelf Life
  • Pooling Batches for Stability Studies
  • Validating Model Assumptions
  • Handing Non-Normal Response Data
  • Introduction to Accelerated Stability Testing
  • Issues & Guidelines

Areas Covered in the Webinar:

  • Planning a Stability Study
  • Determining Performance Specifications
  • Defining & Determining Shelf Life
  • Confidence Levels
  • Life Data Analysis Approach for Determining Shelf Life
  • Life Data Analysis with Accelerated Aging
  • Regression Modeling (Linear and Non-Linear) to Assess Stability/Shelf Life
  • Pooling Batches for Stability Studies
  • Validating Model Assumptions
  • Handing Non-Normal Response Data
  • Introduction to Accelerated Stability Testing
  • Issues & Guidelines

Who Will Benefit:

  • R&D Personnel
  • Product Development Personnel
  • Quality Personnel
  • Lab Testing Personnel
  • Operations / Production Managers
  • Quality Assurance Managers, Engineers
  • Process or Manufacturing Engineers or Managers
  • Program or Product Managers
Instructor Profile:
Steven Wachs

Steven Wachs
Principal Statistician, Integral Concepts, Inc

Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. He has worked as a statistician at Ford Motor Company where he has extensive experience in the development of statistical models, reliability analysis, designed experimentation, and statistical process control.

Mr. Wachs is currently a Principal Statistician at Integral Concepts, Inc. where he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity. He also possesses expertise in the application of reliability methods to achieve robust and reliable products as well as estimate and reduce warranty. Mr. Wachs regularly speaks at industry conferences and provides workshops in industrial statistical methods worldwide.

He has an M.A. in Applied Statistics from the University of Michigan, an M.B.A, Katz Graduate School of Business from the University of Pittsburgh, 1992, and a B.S., Mechanical Engineering from the University of Michigan.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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Product Reviews Write review

it was a great presentation on shelf life / stability studies.
- Anonymous

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